FDA 510(k)

MROpen Evo (03-2000-00)；MROpen Evo (03-4000-00)

K 號：K242258 · 2024-11-26

決定日期2024-11-26

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) is the device name listed in this FDA 510(k) record. The listed applicant is Asg Superconductors S.P.A.. It received FDA 510(k) clearance on 2024-11-26 under 510(k) number K242258. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)?

MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Asg Superconductors S.P.A.. The 510(k) number is K242258.

When did MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) receive FDA 510(k) clearance?

MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) received FDA 510(k) clearance on 2024-11-26, under 510(k) number K242258.

Who is the listed applicant for MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)?

The FDA 510(k) record lists Asg Superconductors S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)?

The FDA product code for MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) is LNH.

其他以 Asg Superconductors S.P.A. 為申請人之記錄

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相關器械（代碼：LNH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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